[Federal Register Volume 66, Number 194 (Friday, October 5, 2001)]
[Proposed Rules]
[Pages 50967-50978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-24878]



[[Page 50967]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 81

RIN 0920-ZA01


Guidelines for Determining the Probability of Causation Under the 
Energy Employees Occupational Illness Compensation Program Act of 2000; 
Notice of Proposed Rulemaking

AGENCY: Department of Health and Human Services.

ACTION: Notice of proposed rulemaking.

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SUMMARY: This proposal would implement select provisions of the Energy 
Employees Occupational Illness Compensation Program Act of 2000 
(``EEOICPA'' or ``Act''). The Act requires the promulgation of 
guidelines, in the form of regulations, for determining whether an 
individual with cancer shall be found, ``at least as likely as not,'' 
to have sustained that cancer from exposure to ionizing radiation in 
the performance of duty for nuclear weapons production programs of the 
Department of Energy and its predecessor agencies. The guidelines will 
be applied by the U.S. Department of Labor, which is responsible for 
determining whether to award compensation to individuals seeking 
federal compensation under the Act.

DATES: Comments: The Department invites written comments on this Notice 
of Proposed Rulemaking from interested parties. Comments on the Notice 
of Proposed Rulemaking must be received by December 4, 2001.

ADDRESSES: Address written comments on the notice of proposed 
rulemaking to the NIOSH Docket Officer. Submit comments electronically 
by e-mail to [email protected]. See SUPPLEMENTARY INFORMATION for 
file formats and other information about electronic filing. 
Alternatively, submit printed comments to the following address: NIOSH 
Docket Office, Robert A. Taft Laboratories; M/S C34, 4676 Columbia 
Parkway, Cincinnati, OH 45226.

FOR FURTHER INFORMATION CONTACT: Larry Elliott, Director, Office of 
Compensation Analysis and Support, National Institute for Occupational 
Safety and Health, 4676 Columbia Parkway, MS-R45, Cincinnati, OH 45226, 
Telephone 513-841-4498 (this is not a toll-free number). Information 
requests can also be submitted by e-mail to [email protected]

SUPPLEMENTARY INFORMATION:

I. Comments Invited

    Interested persons or organizations are invited to participate in 
this rulemaking by submitting written views, arguments, 
recommendations, and data. Comments are invited on any topic related to 
this rulemaking. Some generic topics for comment include the following 
questions:
    (1) Does the proposal make appropriate use of current science and 
medicine for evaluating and quantifying cancer risks for DOE workers 
exposed to ionizing radiation in the performance of duty?
    (2) Does the proposal appropriately adapt compensation policy as it 
has been applied for the compensation of veterans with radiation 
exposure from atomic bombs to compensation policy for radiation-exposed 
nuclear weapons production workers?
    (3) Does the proposal appropriately and adequately address the need 
to ensure procedures under this rule remain current with advances in 
radiation health research?
    Comments should identify the author(s), return address, and phone 
number, in case clarification is needed. Comments can be submitted by 
e-mail to: [email protected]. If submitting comments by e-mail, they 
should be provided as a Word or Word Perfect file attachment. Printed 
comments can also be submitted to the address above. The Secretary will 
consider all communications received on or before the closing date for 
comments. All comments submitted will be available for examination in 
the Rule Docket both before and after the closing date for comments. A 
report summarizing each substantive public contact with personnel 
involved in this rulemaking will be filed in the docket. An electronic 
docket containing all comments submitted by e-mail will be available 
over the Internet on the National Institute for Occupational Safety and 
Health (NIOSH) homepage at www.cdc.gov/niosh.
    HHS will request the Advisory Board on Radiation and Worker Health, 
an advisory committee to HHS established under EEOICPA, to conduct a 
technical review of this proposal. Notices announcing the meetings of 
the Board will be published in the Federal Register. The record for 
this rulemaking will remain open until the Board has completed its 
review.

II. Final Rule

    The Department of Health and Human Services (``HHS'') expects to 
issue a final rule within six months of publication of this notice of 
proposed rulemaking.

III. Background

A. Statutory Authority

    The Energy Employees Occupational Illness Compensation Program Act 
of 2000(``EEOICPA''), Public Law 106-398, 114 Stat. 1654, 1654A-1231 
(October 30, 2000), was enacted as Title XXXVI of the Floyd D. Spence 
National Defense Authorization Act for Fiscal Year 2001. EEOICPA 
established a compensation program to provide a lump sum payment of 
$150,000 and medical benefits as compensation to covered employees 
suffering from designated illnesses incurred as a result of their 
exposure to radiation, beryllium, or silica while in the performance of 
duty for the Department of Energy and certain of its vendors, 
contractors, and subcontractors. This legislation also provided for 
payment of compensation to certain survivors of covered employees.
    EEOICPA instructed the President to designate one or more federal 
agencies to carry out the compensation program. Pursuant to this 
statutory provision, the President issued Executive Order 13179 titled 
Providing Compensation to America's Nuclear Weapons Workers, which 
assigned primary responsibility for administering the compensation 
program to the Department of Labor (``DOL''). 65 FR 77,487 (Dec. 7, 
2000). DOL published an interim final rule governing DOL's 
administration of EEOICPA on May 25, 2001 (66 FR 28948).
    The executive order directed HHS to perform several technical and 
policymaking roles in support of the DOL program:
    (1) HHS is to develop guidelines to be used by DOL to assess the 
likelihood that an employee with cancer developed that cancer as a 
result of exposure to radiation in performing his or her duties at a 
DOE facility or Atomic Weapons Employer (AWE) facility. These 
``Probability of Causation'' guidelines are the subject of this 
proposal.
    (2) HHS is also to develop methods to estimate radiation doses 
(``dose reconstruction'') for certain individuals with cancer applying 
for benefits under the DOL program. These methods are being published 
simultaneously with this proposal as an interim final rule with request 
for comments under 42 CFR part 82 in this issue of the Federal 
Register. HHS is to apply these methods to conduct the program of dose 
reconstruction required by EEOICPA.
    (3) HHS is to staff the Advisory Board on Radiation and Worker 
Health and provide it with administrative and other necessary support 
services. The Board, a federal advisory committee, will

[[Page 50968]]

advise HHS in implementing its roles under EEOICPA described here.
    (4) Finally, HHS is to develop and apply procedures for considering 
petitions to be added to the Special Exposure Cohort established under 
EEOICPA by classes of employees. Employees included in the Special 
Exposure Cohort who have a specified cancer and meet other conditions, 
as defined by EEOICPA and DOL regulations (66 FR 28948), qualify for 
compensation under EEOICPA. HHS procedures for considering Special 
Exposure Cohort petitions are under development. HHS expects to issue 
these procedures within the next six months.
    As provided for under section 3625 of EEOICPA, HHS is implementing 
its responsibilities with the assistance of the National Institute for 
Occupational Safety and Health (``NIOSH''), an institute of the Centers 
for Disease Control and Prevention, HHS.

B. Purpose of Probability of Causation Guidelines

    Under EEOICPA, a covered employee seeking compensation for cancer, 
other than as a member of the Special Exposure Cohort seeking 
compensation for a specified cancer, is eligible for compensation only 
if DOL determines that the cancer was ``at least as likely as not'' (a 
50% or greater probability) caused by radiation doses incurred in the 
performance of duty while working for DOE and/or an atomic weapons 
employer (AWE) facility. These guidelines provide DOL with the 
procedure to make these determinations, and specify the information DOL 
will use.
    HHS notes that EEOICPA does not authorize the establishment of new 
radiation protection standards through the promulgation of these 
guidelines, and these proposed guidelines would not constitute such new 
standards.

C. Statutory Requirements for Probability of Causation Guidelines

    Section 3623(c) of EEOICPA makes several general requirements 
concerning the development of these guidelines. It requires the 
guidelines provide for determinations that are based on the radiation 
dose received by the employee, incorporating the methods of dose 
reconstruction to be established by HHS. It requires determinations be 
based on the upper 99 percent ``confidence interval'' (credibility 
limit) of the probability of causation in the radioepidemiological 
tables published under section 7(b) of the Orphan Drug Act (42 U.S.C. 
241 note), as such tables may be updated. EEOICPA also requires HHS to 
consider the type of cancer, past health-related activities, the risk 
of developing a radiation-related cancer from workplace exposure, and 
other relevant factors. It is also important to note EEOICPA does not 
include a requirement limiting the types of cancers to be considered 
radiogenic for these guidelines.

D. Understanding Probability of Causation

    Probability of Causation is a technical term generally meaning an 
estimate of the percentage of cases of illness caused by a health 
hazard among a group of persons exposed to the hazard. This estimate is 
used in compensation programs as an estimate of the probability or 
likelihood that the illness of an individual member of that group was 
caused by exposure to the health hazard. Other terms for this concept 
include ``assigned share'' and ``attributable risk percent''.
    In this proposal, the potential hazard is ionizing radiation to 
which U.S. nuclear weapons workers were exposed in the performance of 
duty; the illnesses are specific types of cancer. The probability of 
causation (PC) is calculated as the risk of cancer attributable to 
radiation exposure (RadRisk) divided by the sum of the baseline risk of 
cancer to the general population (BasRisk) plus the risk attributable 
to the radiation exposure, then multiplied by 100 percent, as follows:
[GRAPHIC] [TIFF OMITTED] TP05OC01.014

This calculation provides a percentage estimate between 0 and 100 
percent, where 0 would mean 0 likelihood that radiation caused the 
cancer and 100 would mean 100 percent certainty that radiation caused 
the cancer.
    Scientists evaluate the likelihood that radiation caused cancer in 
a worker by using medical and scientific knowledge about the 
relationship between specific types and levels of radiation dose and 
the frequency of cancers in exposed populations. Simply explained, if 
research determines that a specific type of cancer occurs more 
frequently among a population exposed to a higher level of radiation 
than a comparable population (a population with less radiation exposure 
but similar in age, gender, and other factors that have a role in 
health), and if the radiation exposure levels are known in the two 
populations, then it is possible to estimate the proportion of cancers 
in the exposed population that may have been caused by a given level of 
radiation.
    If scientists consider this research sufficient and of reasonable 
quality, they can then translate the findings into a series of 
mathematical equations that estimate how much the risk of cancer in a 
population would increase as the dose of radiation incurred by that 
population increases. The series of equations, known as a dose-response 
or quantitative risk assessment model, may also take into account other 
health factors potentially related to cancer risk, such as gender, 
smoking history, age at exposure (to radiation), and time since 
exposure. The risk models can then be applied as an imperfect but 
reasonable approach to determine the likelihood that the cancer of an 
individual worker was caused by his or her radiation dose.

E. Development and Use of Radioepidemiological Tables and Interactive 
RadioEpidemiological Program (IREP)

    In 1985, in response to a congressional mandate in the Orphan Drug 
Act, a panel established by the National Institutes of Health developed 
a set of radioepidemiological tables. The tables serve as a reference 
tool providing probability of causation estimates for individuals with 
cancer who were exposed to ionizing radiation. Use of the tables 
requires information about the person's dose, gender, age at exposure, 
date of cancer diagnosis and other relevant factors. The tables are 
used by the Department of Veterans Affairs (DVA) to make compensation 
decisions for veterans with cancer who were exposed in the performance 
of duty to radiation from atomic weapon detonations.
    The primary source of data for the 1985 tables is research on 
cancer-related deaths occurring among Japanese atomic bomb survivors 
from World War II.
    The 1985 tables are presently being updated by the National Cancer 
Institute (NCI) and the Centers for Disease Control and Prevention \1\ 
to incorporate progress in research on the relationship between 
radiation and cancer risk. The draft update has been reviewed by the 
National Research Council \2\. DOL will employ the updated version of 
the tables, with certain additional modifications important to claims 
under EEOICPA (described under ``G'' below), as a basis for determining 
probability of

[[Page 50969]]

causation for employees covered under EEOICPA.
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    \1\ Draft Report of the NCI-CDC Working Group to Revise the 1985 
NIH Radioepidemiological Tables, May 31, 2000.
    \2\ A Review of the Draft Report of the NCI-CDC Working Group to 
Revise the ``1985 Radioepidemiological Tables'', National Research 
Council.
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    A major scientific change achieved by this update is the use of 
risk models developed from data on the occurrence of cancers (cases of 
illness) rather than the occurrence of cancer deaths among Japanese 
atomic bomb survivors. The risk models are further improved by being 
based on more current data as well. Many more cancers have been modeled 
in the revised report. The new risk models also take into account 
factors that modify the effect of radiation on cancer, related to the 
type of radiation dose, the amount of dose, and the timing of the dose.
    A major technological change accompanying this update, which 
represents a scientific improvement, is the production of a computer 
software program for calculating probability of causation. This 
software program, named the Interactive RadioEpidemiological Program 
(IREP), allows the user to apply the NCI risk models directly to data 
on an individual employee. This makes it possible to estimate 
probability of causation using better quantitative methods than could 
be incorporated into printed tables. In particular, IREP allows the 
user to take into account uncertainty concerning the information being 
used to estimate probability of causation. There typically is 
uncertainty about the radiation dose levels to which a person has been 
exposed, as well as uncertainty relating levels of dose received to 
levels of cancer risk observed in study populations.
    Accounting for uncertainty is important because it can have a large 
effect on the probability of causation estimates. DVA, in their use of 
the 1985 radioepidemiological tables, uses the probability of causation 
estimates found in the tables at the upper 99 percent credibility 
limit. This means when DVA determines whether the cancer of a veteran 
was more likely than not caused by radiation, they use the estimate 
that is 99 percent certain to be greater than the probability that 
would be calculated if the information on dose and the risk model were 
perfectly accurate. Similarly, these HHS guidelines, as required by 
EEOICPA, will use the upper 99 percent credibility limit to determine 
whether the cancers of employees are at least as likely as not caused 
by their occupational radiation doses. This will help minimize the 
possibility of denying compensation to claimants under EEOICPA for 
those employees with cancers likely to have been caused by occupational 
radiation exposures.

F. Use of IREP for Energy Employees

    The risk models developed by NCI and CDC for IREP provide the 
primary basis for developing guidelines for estimating probability of 
causation under EEOICPA. They directly address 33 cancers and most 
types of radiation exposure relevant to employees covered by EEOICPA. 
These models take into account the employee's cancer type, year of 
birth, year of cancer diagnosis, and exposure information such as years 
of exposure, as well as the dose received from gamma radiation, x rays, 
alpha radiation, beta radiation, and neutrons during each year. The 
risk model for lung cancer takes into account smoking history as well. 
None of the risk models explicitly accounts for exposure to other 
occupational, environmental, or dietary carcinogens. Models accounting 
for these factors have not been developed and may not be possible to 
develop based on existing research. Moreover, DOL could not 
consistently or efficiently obtain the data required to make use of 
such models.
    IREP models do not specifically include cancers as defined in their 
early stages: Carcinoma in situ (CIS). These lesions are becoming more 
frequently diagnosed, as the use of cancer screening tools, such as 
mammography, have increased in the general population. The risk factors 
and treatment for CIS are frequently similar to those for malignant 
neoplasms, and, while controversial, there is growing evidence that CIS 
represents the earliest detectable phase of malignancy \3\. Therefore, 
for determining compensation under EEOICPA, HHS is proposing that CIS 
be treated as a malignant neoplasm of the specified site.
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    \3\ Kerlikowske, K, J Barclay, D Grady, EA Sickles, and V 
Ernster. ``Comparison of risk factors for ductal carcinoma in situ 
and invasive breast cancer.'' J. Natl. Canc. Inst. 89:76-82, 1997.
    Grippo, PJ, and EP Sandgren. ``Highly invasive transitional cell 
carcinoma of the bladder in a simian virus 40 T-antigen transgenic 
mouse model''. Am. J. Pathol. 157:805-813, 2000.
    Correa P. ``Morphology and natural history of cancer 
precursors'' Chapter 4 in: Cancer Epidemiology and Prevention, 2nd 
Edition, D Schottenfeld and JF Fraumeni Jr, eds. New York: Oxford 
University Press, 1996.
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    Cancers identified by their secondary sites (sites to which a 
malignant cancer has spread), when the primary site is unknown, raise 
another issue for the application of IREP. This situation will most 
commonly arise when death certificate information is the primary source 
of a cancer diagnosis. It is accepted in medicine that cancer-causing 
agents such as ionizing radiation produce primary cancers. This means, 
in a case in which the primary site of cancer is unknown, the primary 
site must be established by inference to estimate probability of 
causation.
    HHS is proposing to establish such assignments in these guidelines, 
based on an evaluation of the relationship between primary and 
secondary cancer sites using the National Center for Health Statistics 
(NCHS) Mortality Database for years 1995-1997. Because national cancer 
incidence databases (e.g., the National Cancer Institute's 
Surveillance, Epidemiology and End Results program) do not contain 
information about sites of metastasis, the NCHS database is the best 
available data source at this time to assign the primary site(s) most 
likely to have caused the spread of cancer to a known secondary site. 
For each secondary cancer, the set of primary cancers producing 
approximately 75% of that secondary cancer among the U.S. population 
was identified (males and females were considered separately). The sets 
are tabulated in this rule (Table 1). HHS is proposing that the final 
assignment of a primary cancer site for an individual claim would be 
determined by DOL on a case-by-case basis, as the site among possible 
primary sites which results in the highest probability of causation 
estimate.
    Employees diagnosed with two or more primary cancers also raise a 
special issue for determining probability of causation. Even under the 
assumption that the biological mechanisms by which each cancer is 
caused are unrelated, uncertainty estimates about the level of 
radiation delivered to each cancer site will be related. While fully 
understanding this situation requires statistical training, the 
consequence has simple but important implications. Under this proposal, 
instead of determining the probability that each cancer was caused by 
radiation, DOL would have to perform an additional statistical 
procedure following the use of IREP to determine the probability that 
at least one of the cancers was caused by the radiation. This approach 
is important to the claimant because it would determine a higher 
probability of causation than would be determined for either cancer 
individually.

G. Limitations of IREP for Energy Employees

    IREP is being developed to serve the needs of DVA in deciding 
cancer compensation claims for veterans. This means IREP has to be 
adapted in various ways to meet the needs of DOL, because the radiation 
exposure experience of

[[Page 50970]]

employees covered by EEOICPA differs substantially.
    Some employees covered by EEOICPA were substantially exposed to 
radon and other sources of high linear energy transfer (LET) radiation. 
This type of radiation exposure has unique properties affecting cancer 
risk, which are not addressed in the risk models included in IREP. 
Specifically, the IREP risk models do not account for a possible 
inverse dose-rate effect for high-LET radiation exposures. This effect 
means at any particular dose level, especially higher dose levels, a 
dose of high LET radiation incurred gradually over time is more likely 
to cause cancer than the same total dose incurred quickly or at once. A 
substantial body of research supports this finding, including studies 
of uranium miners,\4\ patients exposed to bone-seeking radium alpha 
particles,\5\ and research on the cancer effects of high LET radiation 
in animals.\6\ Because high-LET radiation is an important type of 
radiation exposure among employees covered by EEOICPA, NIOSH will 
modify IREP to include uncertainty associated with the assumption of an 
inverse dose-rate effect for these exposures.
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    \4\ Hornung RW, Meinhardt TJ. Quantitative risk assessment of 
lung cancer in U.S. uranium miners. Health Phys 52: 417-430, 1987.
    Lubin JH, Boice JD Jr, Edling C, et al. Radon-exposed 
underground miners and the inverse dose-rate (protraction 
enhancement) effects. Health Phys 69:494-500, 1995.
    \5\ Mays CW, Spiess H. Bone sarcomas in patients given radium-
224. In: Radiation Carcinogenesis: Epidemiology and Biological 
Significance. Boice JD Jr, Fraumeni JF Jr (eds): New York: Raven 
Press, pp 241-252, 1984.
    \6\ Luebeck EG, Curtis SB, Cross FT, Moolgavkar SH. Two-stage 
model of radon-induced malignant lung tumors in rats: effects of 
cell killing. Radiat. Res. 145:163-173, 1996.
    Hall EJ, Miller RC, Brenner DJ. Neoplastic transformation and 
the inverse dose-rate effect for neutrons. Radiat. Res. 128 (Suppl): 
S75-S80, 1991.
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    The DOE workforce has been exposed to various types of neutron 
energies and these exposures are frequently documented in the worker's 
dosimetry records. The relative biological effectiveness (RBE) of 
radiation exposure, a factor in cancer risk models that accounts for 
the differing level of cancer risk associated with different forms of 
radiation, varies as a function of neutron energy.\7\ This variation in 
RBE related to differing neutron energy is not accounted for in the 
current version of IREP, which contains a single neutron RBE 
distribution. Therefore, NIOSH will modify IREP for DOE workers to 
include different RBE distributions for neutrons of various energies.
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    \7\ International Commission on Radiological Protection (ICRP) 
60: ``1990 Recommendations of the International Commission on 
Radiological Protection.'' Ann. ICRP 21(1-3):1-201.
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    The currently-available draft of IREP does not incorporate a unique 
lung cancer model for radon exposure, which is an important exposure 
for some workers covered under EEOICPA. Using epidemiologic evidence on 
the lung carcinogenicity of radon exposures, NCI is incorporating a 
lung cancer model for radon exposures into the revised version of IREP. 
The data source for this model is the analysis conducted by the federal 
Radiation Exposure Compensation Act Committee.\8\
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    \8\ Final Report of the Radiation Exposure Compensation Act 
Committee, submitted to the Human Radiation Interagency Working 
Group, July 1996 (Appendix A), 30 pp (plus Figures).
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    NIOSH will modify IREP to eliminate an assumption for non-leukemia 
cancers that low-level acute radiation doses (defined in IREP as doses 
between 3 and 30 cSv) cause less risk, per unit of dose, than higher 
level acute doses. A recent study of the Japanese atomic bomb survivors 
supports this change.\9\
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    \9\ Pierce DA and Preston DL ``Radiation-related cancer risks at 
low doses among atomic bomb survivors.'' Radiat. Res. 154:178-186, 
2000.
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    Additionally, some employees covered by EEOICPA were required, as a 
condition of employment, to undergo routine medical screening with x 
rays. The dose resulting from these x rays will be included in their 
dose reconstruction. This requires NIOSH to add to IREP an RBE 
distribution appropriate to the low-energy form of radiation produced 
from some of these x rays.\10\
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    \10\ ICRU Report 40: The quality factor in radiation protection. 
Internat. Commission on Radiat. Units and Meas., 33 pp, 1986.
    Hall EJ. ``Linear energy transfer and relative biological 
effectiveness''. Chapter 9 in Radiobiology for the Radiobiologist, 
4th Edition. Philadelphia: J.B. Lippincott, 1994.
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    There is no risk model in IREP for estimating the probability of 
causation of bone cancer by high-LET radiation exposure. Research has 
found bone cancer risk substantially and significantly elevated among 
animals and humans exposed to certain forms of high-LET radiation.\11\ 
NIOSH will add a risk model for bone cancer, based on recently 
completed assessments of risks associated with plutonium exposures.\12\
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    \11\ International Agency for Research on Cancer (IARC). IARC 
Monographs on the Evaluation of Carcinogenic Risks to Humans, Vol. 
78 Ionizing Radiation, Part 2: Some Internally Deposited 
Radionuclides. Lyon, France: IARC Press, 595 pp, 2001.
    \12\ Grogan HA, Sinclair WK, and Voilleque PG. ``Risks of fatal 
cancer from inhalation of 239,240plutonium by humans: a 
combined four-method approach with uncertainty evaluation'' Health 
Physics 80:447-461, 2001.
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    Limitations of current research and development have prevented 
NIOSH from considering and implementing all possible improvements to 
IREP at the time of this proposal. In the future, NIOSH may make 
additional changes in IREP to address differences in radiation-related 
cancer risk between Japanese atomic bomb survivors and employees 
involved in nuclear weapons production. Some research has shown 
substantial differences in risk for certain cancers, such as brain 
cancer and multiple myeloma.\13\ The radiation-related risk of these 
cancers is significantly elevated among employees involved in nuclear 
weapons production, whereas it is not among the Japanese study 
population. The IREP risk models for these cancers were produced using 
data from the Japanese study population.
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    \13\ Alexander V and DiMarco JH. ``Reappraisal of brain tumor 
risk among U.S. nuclear workers: a 10-year review.'' Occupational 
Medicine: State of the Art Reviews 16(2):289-315, 2001.
    Cardis E, Gilbert ES, Carpenter L, et al. ``Effects of low doses 
and low dose rates of external ionizing radiation: cancer mortality 
among nuclear industry workers in three countries.'' Radiat. Res. 
142:117-132, 1995.
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    Similarly, it may be possible to improve the fit of IREP risk 
models to employees covered by EEOICPA with respect to differences 
between the frequency of certain cancers in the general population in 
the United States versus Japan. The IREP risk models include a 
simplistically derived factor (risk transfer) that accounts for these 
differences, based on expert judgment. For some cancers, such as breast 
and stomach cancer, sufficient research may exist to improve this 
factor. In addition, where current IREP risk models could be replaced 
with risk models based on studies of U.S. DOE workers, or other U.S. 
populations, this factor could be omitted entirely.
    The potential future use of risk models based on studies of U.S. 
DOE workers may also eliminate limitations arising because data are 
sparse for certain cancers among the Japanese atomic bomb survivors, 
such as most specific types of leukemia. Using data on the Japanese 
cohort, the effect on risk of age at time of exposure to radiation, an 
important modifier of leukemia risk, cannot be estimated for specific 
types of leukemia, except chronic myeloid leukemia. It can only be 
estimated for other leukemia types by using a general leukemia model 
that combines data from cases of different types of leukemia.
    Finally, NIOSH may make modifications in cancer risk models in 
IREP, as appropriate and if feasible, to account for the changing 
frequency among the general population (baseline

[[Page 50971]]

rates) of certain types of cancer in the United States. Certain types 
of cancer (e.g., lung cancer among women, breast cancer) have become 
more frequent in recent decades. Similarly, HHS may make modifications 
in cancer risk models to reflect the differing frequency of certain 
types of cancer among different racial and ethnic groups in the United 
States (e.g., multiple myeloma, skin cancers). The effect of these 
modifications, at such time as they may become feasible, would be to 
improve the accuracy of probability of causation estimates.

H. Procedures for review and public comment on NIOSH-IREP

    As described under Section G above, certain current and potential 
future changes to the cancer risk models in IREP are particularly 
appropriate for addressing the radiation exposures and statutory 
requirements of claimants under EEOICPA. As a result, the version of 
IREP to include NIOSH modifications will be unique and distinguished as 
``NIOSH-IREP.'' This version, which DOL will use to estimate 
probability of causation under EEOICPA, will be reviewed by the 
Advisory Board on Radiation and Worker Health. NIOSH-IREP will be 
available for public review on the NIOSH homepage at: www.cdc.gov/niosh, by September 30, 2001. NIOSH-IREP will include documentation of 
underlying risk models and calculations. The public will also be able 
to obtain complete information about NIOSH-IREP, including printed 
reports, by contacting NIOSH at its toll-free telephone information 
service: 1-800-35-NIOSH (1-800-356-4674).
    The public may comment on NIOSH-IREP at any time. Comments should 
be sent to NIOSH following instructions at the NIOSH-IREP web page 
cited above, or by sending printed comments to: NIOSH-IREP Comments, 
National Institute for Occupational Safety and Health, 4676 Columbia 
Parkway, MS-R45, Cincinnati, Ohio 45226.
All comments will be considered. In addition, NIOSH will forward all 
substantive comments to the Advisory Board on Radiation and Worker 
Health.

I. Updating NIOSH-IREP

    NIOSH will periodically revise NIOSH-IREP to add, modify, or 
replace cancer risk models, improve the modeling of uncertainty, and 
improve the functionality and user-interface of NIOSH-IREP. Primary 
sources of potential improvements in cancer risk models include new 
epidemiologic research on DOE employee populations and periodic updates 
from scientific committees evaluating such research (e.g., the 
Committee on Biological Effects of Ionizing Radiation). Further 
description of the rationale for such scientific improvements is 
described under paragraph II.G. above.
    Improvements may also be directly recommended by the Advisory Board 
on Radiation and Worker Health, scientific reviews relevant to or 
addressing this program, public comment, or by DOL, which is the 
principal user and hence may require functional changes and 
improvements in the user-interface.
    Substantive changes to NIOSH-IREP (changes that would substantially 
affect estimates of probability of causation calculated using NIOSH-
IREP, including the addition of new cancer risk models) will be 
submitted to the Advisory Board on Radiation and Worker Health for 
review. Proposed changes provided to the Advisory Board for review will 
also be made available to the public. Instructions for obtaining 
relevant materials and providing public comment will be provided in the 
notice of the Advisory Board meeting, published in the Federal 
Register.

J. Public notice on plans and changes implemented to update NIOSH-IREP

    NIOSH will periodically publish a notice in the Federal Register 
informing the public of proposed substantive changes to NIOSH-IREP 
currently under development, the status of the proposed changes, and 
the expected completion dates. NIOSH will also publish a notice in the 
Federal Register notifying the public of substantial changes to NIOSH-
IREP (changes that would substantially affect estimates of probability 
of causation calculated using NIOSH-IREP, including the addition of new 
cancer risk models). In the notice, NIOSH will address relevant 
comments received by NIOSH.

K. Operating Guide for NIOSH-IREP

    DOL will use procedures specified in the NIOSH-IREP Operating Guide 
to calculate probability of causation estimates under EEOICPA. The 
guide provides current, step-by-step instructions for the operation of 
NIOSH-IREP. The procedures include entering personal, diagnostic, and 
exposure data; setting/confirming appropriate values for variables used 
in calculations; conducting the calculation; and, obtaining, 
evaluating, and reporting results.
    An initial version of the NIOSH-IREP Operating Guide will be 
available to the public online on the NIOSH homepage at: www.cdc.gov/niosh, by September 30, 2001. The public will be able to obtain printed 
copies by contacting NIOSH at its toll-free telephone information 
service: 1-800-35-NIOSH (1-800-356-4674).

L. Cancer Unrelated to Radiation

    Chronic lymphocytic leukemia (CLL) is a form of leukemia not found 
to be radiogenic in studies conducted worldwide of a wide variety of 
radiation-exposed populations, including the Japanese atomic bomb 
survivors, persons exposed to x rays and Thorotrast during medical 
treatment, and nuclear industry workers.\14\ Therefore, for the 
purposes of this proposed rule, the probability of causation for CLL 
would be assigned a value of zero. HHS may modify this provision in 
response to new scientific findings.
---------------------------------------------------------------------------

    \14\ Andersson, M, Carstensen B, Visfeldt J. ``Leukemia and 
other related hematological disorders among Danish patients exposed 
to Thorotrast.'' Radiat Res 134:224-233, 1993.
    Cardis E, Gilbert ES, Carpenter L, et al. ``Effects of low doses 
and low dose rates of external ionizing radiation: cancer mortality 
among nuclear industry workers in three countries.'' Radiat. Res. 
142:117-132, 1995.
    Curtis RE, Boice JD Jr, Stovall M, et al. ``Relationship of 
leukemia risk to radiation dose following cancer of the uterine 
corpus.'' J Natl Canc Inst 86:1315-1324, 1994.
    Darby SC Doll R, Gill SK, et al. ``Long-term mortality after a 
single treatment course with x rays in patients treated for 
ankylosing spondylitis.'' Br J Cancer 55:179-190, 1987.
    International Agency for Research on Cancer (IARC). IARC 
Monographs on the Evaluation of Carcinogenic Risks to Humans. Vol. 
78. Ionizing Radiation, Part 2: Some Internally Deposited 
Radionuclides. Lyon, France: IARC press. 595 p, 2001.
    Muirhead CR, Goodill AA, Haylock RGE et al. ``Occupational 
radiation exposure and mortality second analysis of the National 
Registry for Radiation Workers.'' J Radiol Prot 19:3-26, 1999.
    Preston DL, Kusumi S, Tomonaga M, et al. ``Cancer incidence in 
atomic bomb survivors. Part III: Leukemia, lymphoma and multiple 
myeloma, 1950-1987.'' Radiat Res 137:S68-S97, 1994.
---------------------------------------------------------------------------

IV. History of Rule Development

A. NIOSH Research on the Health of DOE Workers

    Expert judgment has been applied to modify certain IREP risk models 
and develop guidelines for applying these models appropriately for 
employees covered by EEOICPA. An important basis for this judgment has 
been the research experience of NIOSH and its external research 
partners on radiation-related cancers among DOE employees and U.S. 
uranium miners. NIOSH has conducted a program of federally sponsored 
health research on DOE employees since 1991. NIOSH completed the 
principal occupational health research establishing lung cancer risks 
associated with radon exposure among uranium miners.

[[Page 50972]]

B. Relationship With NCI-CDC Update of Radioepidemiological Tables

    Within HHS, NIOSH and NCI have worked closely together to adapt the 
NCI-CDC update of the radioepidemiological tables, developed as IREP, 
to meet as many of the needs of employees covered by EEOICPA as 
possible. Some potential changes could not be accomplished before 
initial implementation of the compensation program under EEOICPA. NIOSH 
and NCI will continue collaborating to address these needs. Other 
changes uniquely useful for employees covered by EEOICPA, as discussed 
in this Preamble, will be incorporated into the version of IREP 
designed specifically for employees covered by EEOICPA.

C. Technical Review by the Advisory Board on Radiation and Worker 
Health

    NIOSH anticipates that the guidelines in this proposed rule will be 
reviewed by the Advisory Board on Radiation and Worker Health, which is 
required by Section 3623(c) of EEOICPA. HHS will consider any findings 
of this review in promulgating the final regulation.

D. Consultation With Experts and Interested Parties

    HHS has consulted individually with a wide variety of experts and 
interested parties to help ensure the quality and practicality of these 
guidelines. Reports on these consultations are available in the 
regulatory docket for public review.

V. Summary of Proposed Rule

    Congress, in enacting EEOICPA, created a new Energy Employees 
Occupational Illness Compensation Program to ensure an efficient, 
uniform, and adequate compensation system for certain employees. 
Through Executive Order 13179, the President assigned primary 
responsibility for administering the program to DOL. The President 
assigned various technical responsibilities for policymaking and 
assistance to HHS. Included among these is promulgation of this 
proposed rule to establish guidelines DOL will apply to adjudicate 
cancer claims for covered employees seeking compensation for cancer, 
other than as members of the Special Exposure Cohort seeking 
compensation for a specified cancer. Sections 81.20-81.25 and 81.30 
provide guidelines for determining the probability of causation with 
respect to all known cancers.

Introduction

    Sections 81.0 and 81.1 briefly describe how this proposed rule 
relates to DOL authorities under EEOICPA and the assignment of 
authority for this rule to HHS. Section 81.2 summarizes the specific 
provisions of EEOICPA directing HHS in the development of this proposed 
rule.

Definitions

    This section of the regulation proposes definitions for the 
principal terms used in this part. It includes terms specifically 
defined in EEOICPA that, for the convenience of the reader of this 
part, are repeated in this section.

Data Required To Estimate Probability of Causation

    Sections 81.5 and 81.6 propose the sources and types of personal, 
medical, and radiation dose information that would be required by this 
regulation. Claimants will provide personal and medical information to 
DOL under DOL regulations 20 CFR part 30. NIOSH will provide radiation 
dose information pursuant to 20 CFR part 30. NIOSH will develop the 
dose information required pursuant to the HHS regulation under 42 CFR 
part 82 (published in this issue of the Federal Register), which is 
being promulgated concurrently with this proposed rule. The application 
of this personal, medical, and radiation dose information to estimate 
probability of causation is described generally under Secs. 81.22-
81.25.

Requirements for Risk Models Used To Estimate Probability of Causation

    Sections 81.10 and 81.11 describe the use of the risk models and 
uncertainty analysis underlying the NIH Radioepidemiological Tables in 
their current, updated form, which is a software program named the 
``Interactive RadioEpidemiological Program'' (IREP). IREP is discussed 
extensively above. These sections also propose criteria by which these 
risk models may be changed to ensure that probability of causation 
estimates calculated by EEOICPA represent the unique exposure and 
disease experiences of employees covered by EEOICPA. HHS seeks comments 
on these criteria.

Guidelines To Estimate Probability of Causation

    Sections 81.20 and 81.21 propose requiring DOL to use NIOSH-IREP to 
estimate probability of causation for cancers for which probability of 
causation estimates can be calculated using available cancer risk 
models. Section 81.21 also proposes requiring DOL to assume carcinoma 
in situ (ICD-9 \15\ codes 230-234), neoplasms of uncertain behavior 
(ICD-9 codes 235-238), and neoplasms of unspecified nature (ICD-9 code 
239) are malignant, for purposes of estimating probability of 
causation. HHS seeks comment on these assumptions and any conditions or 
limitations that should be considered with regard to these assumptions.
---------------------------------------------------------------------------

    \15\ ICD-9 is a version of the standard system of classifying 
diseases that will be used by IREP. The most recent version of this 
system, ICD-10, will not be used because the cancer risk models have 
been constructed using ICD-9.
    See: The International Classification of Diseases Clinical 
Modification (9th Revision) Volume I&II. [1991] Department of Health 
and Human Services Publication No. (PHS) 91-1260, U.S. Government 
Printing Office, Washington D.C.
---------------------------------------------------------------------------

    Sections 81.22-81.25 propose general guidelines for the use of 
NIOSH-IREP and specific applications to accommodate special 
circumstances anticipated. The special circumstances include claims in 
which: (1) The primary site of a metastasized cancer is unknown; (2) 
the subtype of leukemia presented lacks a single, optimal risk model in 
NIOSH-IREP; and (3) two or more primary cancers are presented, 
requiring further statistical adjustment of probability of causation 
estimates calculated using NIOSH-IREP.
    The procedure concerning subtypes of leukemia (2) is needed because 
of a limitation of the data on Japanese atomic bomb survivors, as 
discussed previously in this proposal. The general leukemia model in 
IREP allows for adjustment for age at exposure, which is an important 
modifier of leukemia risk. The data are too sparse, however, to allow 
for such an adjustment with respect to specific types of leukemia, with 
the exception of chronic myeloid leukemia. Since it is not possible to 
determine which factor, age at exposure or leukemia subtype, is more 
important to determining probability of causation for most specific 
types of leukemia, the guidelines would require use of both the general 
model and the specific model. The guidelines propose requiring DOL to 
use the findings of whichever model produces the higher probability of 
causation estimate.
    HHS seeks comments on the strategies adopted in this proposed rule 
to address each of these special circumstances, and on other needs not 
identified in this proposal.
    Section 81.30 proposes non-radiogenic cancers for which DOL would 
assign a value of zero to the probability of causation. Chronic 
Lymphocytic Leukemia (ICD-9 Code: 204.1) is the only cancer specified. 
HHS is seeking comments on this section. The public should be aware 
that the addition of cancers to this section would require broadly 
established

[[Page 50973]]

consensus of non-radiogenicity among the medical and scientific 
communities.

VI. Significant Regulatory Action (Executive Order 12866)

    This rule is a ``significant regulatory action,'' within the 
meaning of Executive Order 12866, because it raises novel or legal 
policy issues arising out of the legal mandate established under 
EEOICPA. The rule is designed to establish objective guidelines, 
grounded in current science, to support DOL in the adjudication of 
applicable claims seeking compensation for cancer under EEOICPA. The 
guidelines will be applied by DOL to calculate a reasonable, 
scientifically supported determination of the probability that a cancer 
for which a claimant is seeking compensation was as likely as not 
caused by radiation doses incurred in the performance of duty by the 
covered employee. The financial cost to the federal government of 
applying these guidelines is covered under administrative expenses 
estimated by DOL under its rule (see FR 28948, May 25, 2001).
    The proposed rule carefully explains the manner in which the 
regulatory action is consistent with the mandate for this action under 
section 3623(c) of EEOICPA and implements the detailed requirements 
concerning this action under this section of EEOICPA. The proposed rule 
does not interfere with State, local, and tribal governments in the 
exercise of their governmental functions.
    The proposed rule is not considered economically significant, as 
defined in section 3(f)(1) of the Executive Order 12866. This proposal 
has a subordinate role in the adjudication of claims under EEOICPA, 
serving as one element of an adjudication process administered by DOL 
under 20 CFR parts 1 and 30. DOL has determined that its rule fulfills 
the requirements of Executive Order 12866 and provides estimates of the 
aggregate cost of benefits and administrative expenses of implementing 
EEOICPA under its rule (see FR 28948, May 25, 2001).

VII. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., 
requires each agency to consider the potential impact of its 
regulations on small entities including small businesses, small 
governmental units, and small not-for-profit organizations. We certify 
that this proposed rule will not have a significant economic impact on 
a substantial number of small entities within the meaning of the RFA. 
This proposal affects only DOL, HHS, and some individuals filing 
compensation claims under EEOICPA. Therefore, a regulatory flexibility 
analysis as provided for under RFA is not required.

VIII. Paperwork Reduction Act

    The Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., requires 
an agency to invite public comment on and to obtain OMB approval of any 
regulation that requires ten or more people to report information to 
the agency or to keep certain records. This proposed rule does not 
contain any information collection requirements. It provides guidelines 
only to the U.S. Department of Labor (DOL) for adjudicating 
compensation claims and thus requires no reporting or recordkeeping. 
Information required by DOL to apply these guidelines is being provided 
by HHS and by individual claimants to DOL under DOL regulations 20 CFR 
part 30 (see 66 FR 28948, May 25, 2001). Thus, HHS has determined that 
the PRA does not apply to this proposed rule.

IX. Small Business Regulatory Enforcement Fairness Act

    As required by Congress under the Small Business Regulatory 
Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), the Department 
will report to Congress promulgation of this proposed rule prior to its 
effective date. The report will state that the Department has concluded 
that this proposed rule is not a ``major rule'' because it is not 
likely to result in an annual effect on the economy of $100 million or 
more. However, this proposed rule has a subordinate role in the 
adjudication of claims under EEOICPA, serving as one element of an 
adjudication process administered by DOL under 20 CFR parts 1 and 30. 
DOL has determined that its rule is a ``major rule'' because it will 
likely result in an annual effect on the economy of $100 million or 
more.

X. Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531 
et seq.) directs agencies to assess the effects of Federal regulatory 
actions on State, local, and tribal governments, and the private 
sector, ``other than to the extent that such regulations incorporate 
requirements specifically set forth in law.'' For purposes of the 
Unfunded Mandates Reform Act, this proposed rule does not include any 
Federal mandate that may result in increased annual expenditures in 
excess of $100 million by State, local or tribal governments in the 
aggregate, or by the private sector.

XI. Executive Order 12988 (Civil Justice)

    This proposed rule has been drafted and reviewed in accordance with 
Executive Order 12988, Civil Justice Reform and will not unduly burden 
the Federal court system. Probability of causation may be an element in 
reviews of DOL adverse decisions in the United States District Courts 
pursuant to the Administrative Procedure Act. However, DOL has 
attempted to minimize that burden by providing claimants an opportunity 
to seek administrative review of adverse decisions, including those 
involving probability of causation. HHS has provided a clear legal 
standard for DOL to apply regarding probability of causation. This 
proposal has been reviewed carefully to eliminate drafting errors and 
ambiguities.

XII. Executive Order 13132 (Federalism)

    The Department has reviewed this proposed rule in accordance with 
Executive Order 13132 regarding federalism, and has determined that it 
does not have ``federalism implications.'' The proposed rule does not 
``have substantial direct effects on the States, on the relationship 
between the national government and the States, or on the distribution 
of power and responsibilities among the various levels of government.''

XIII. Executive Order 13045 (Protection of Children From 
Environmental, Health Risks and Safety Risks)

    In accordance with Executive Order 13045, HHS has evaluated the 
environmental health and safety effects of this proposed rule on 
children. The agency has determined that the rule would have no effect 
on children.

XIV. Executive Order 13211 (Actions Concerning Regulations that 
Significantly Affect Energy Supply, Distribution, or Use)

    In accordance with Executive Order 13211, HHS has evaluated the 
effects of this proposed rule on energy supply, distribution or use, 
and has determined that the rule is not likely to have a significant 
adverse effect on them.

List of Subjects in 42 CFR Part 81

    Cancer, Government Employees, Radiation protection, Radioactive 
materials, Workers' compensation.

Text of the Rule

    For the reasons discussed in the preamble, the Department of Health 
and Human Services proposes to amend 42 CFR to add part 81 to read as 
follows:

[[Page 50974]]

PART 81--GUIDELINES FOR DETERMINING PROBABILITY OF CAUSATION UNDER 
THE ENERGY EMPLOYEES OCCUPATIONAL ILLNESS COMPENSATION PROGRAM ACT 
OF 2000

Subpart A--Introduction

Sec.
81.0   Background.
81.1   Purpose and authority.
81.2   Provisions of EEOICPA concerning this rule.

Subpart B--Definitions

81.4   Definition of terms used in this rule.

Subpart C--Data Required To Estimate Probability of Causation

81.5   Use of personal and medical information.
81.6   Use of radiation dose information.

Subpart D--Requirements for Risk Models Used To Estimate 
Probability of Causation

81.10   Use of cancer risk assessment models in NIOSH-IREP.
81.11   Use of uncertainty analysis in NIOSH-IREP.

Subpart E--Guidelines To Estimate Probability of Causation

81.20   Required use of NIOSH-IREP.
81.21   Cancers requiring the use of NIOSH-IREP.
81.22   General guidelines for use of NIOSH-IREP.
81.23   Guidelines for cancers for which primary site is unknown.
81.24   Guidelines for leukemia.
81.25   Guidelines for claims involving two or more primary cancers.
81.30   Non-radiogenic cancers.
Appendix A to Part 81--Glossary of ICD-9 codes and their cancer 
descriptions

    Authority: 42 U.S.C. 7384n; E.O. 13179, 65 FR 77487.

Subpart A--Introduction


Sec. 81.0  Background.

    The Energy Employees Occupational Illness Compensation Program Act 
(EEOICPA), Pub. L. 106-398, provides for the payment of compensation 
benefits to covered employees and, where applicable, survivors of such 
employees, of the United States Department of Energy, its predecessor 
agencies and certain of its contractors and subcontractors. Among the 
types of illnesses for which compensation may be provided are cancers. 
There are two categories of covered employees with cancer under EEOICPA 
for whom compensation may be provided. The regulations that follow 
under this part apply only to the category of employees described under 
paragraph (a) of this section.
    (a) One category is employees with cancer for whom probability of 
causation must be estimated or determined, as required under 20 CFR 
30.115.
    (b) The second category is members of the Special Exposure Cohort 
seeking compensation for a specified cancer, as defined under EEOICPA. 
The U.S. Department of Labor (DOL) which has primary authority for 
implementing EEOICPA, has promulgated regulations at 20 CFR 30.210 and 
30.213 that identify current members of the Special Exposure Cohort and 
requirements for compensation. Pursuant to section 3626 of EEOICPA, the 
Secretary of HHS is authorized to add additional classes of employees 
to the Special Exposure Cohort.


Sec. 81.1  Purpose and authority.

    (a) The purpose of this regulation is to establish guidelines DOL 
will apply to adjudicate cancer claims for covered employees seeking 
compensation for cancer, other than as members of the Special Exposure 
Cohort seeking compensation for a specified cancer. To award a claim, 
DOL must first determine that it is at least as likely as not that the 
cancer of the employee was related to radiation doses incurred by the 
employee in the performance of duty. These guidelines provide the 
procedures DOL must apply and identify the information DOL will use.
    (b) Section 3623(b) of EEOICPA requires the President to promulgate 
these guidelines. Executive Order 13179 assigned responsibility for 
promulgating these guidelines to the Secretary of Health and Human 
Services.


Sec. 81.2  Provisions of EEOICPA concerning this rule.

    EEOICPA imposes several general requirements concerning the 
development of these guidelines. It requires that the guidelines 
produce a determination as to whether it is at least as likely as not 
(a 50% or greater probability) that the cancer of the covered employee 
was related to radiation doses incurred by the employee in the 
performance of duty. It requires the guidelines be based on the 
radiation dose received by the employee, incorporating the methods of 
dose reconstruction to be established by HHS. It requires 
determinations be based on the upper 99 percent confidence interval 
(credibility limit) of the probability of causation in the 
radioepidemiological tables published under section 7(b) of the Orphan 
Drug Act (42 U.S.C. 241 note), as such tables may be updated. EEOICPA 
also requires HHS consider the type of cancer, past health-related 
activities, the risk of developing a radiation-related cancer from 
workplace exposure, and other relevant factors. Finally, it is 
important to note EEOICPA does not include a requirement limiting the 
types of cancers to be considered radiogenic for these guidelines.

Subpart B--Definitions


Sec. 81.4  Definition of terms used in this rule.

    (a) Covered employee: For purposes of this rule, an individual who 
is or was an employee of DOE, a DOE contractor or subcontractor, or an 
atomic weapons employer, and for whom DOL has requested HHS to perform 
a dose reconstruction.
    (b) Dose and dose rate effectiveness factor (DDREF): A factor 
applied to a risk model to modify the dose-risk relationship estimated 
by the model to account for the level of the dose and the rate at which 
the dose is incurred. As used in IREP, a DDREF value of greater than 
one implies that chronic or low doses are less carcinogenic per unit of 
dose than acute or higher doses.
    (c) Dose-response relationship: A mathematical expression of the 
way that the risk of a biological effect (for example, cancer) changes 
with increased exposure to a potential health hazard (for example, 
ionizing radiation).
    (d) EEOICPA: The Energy Employees Occupational Illness Compensation 
Program Act of 2000, Public Law 106-398, as amended.
    (e) Equivalent dose: The absorbed dose in a tissue or organ 
multiplied by a radiation weighting factor to account for differences 
in the effectiveness of the radiation in inducing cancer.
    (f) External dose: The portion of the equivalent dose that is 
received from radiation sources outside of the body.
    (g) Interactive RadioEpidemiological Program (IREP): A computer 
software program that uses information on the dose-response 
relationship, and specific factors such as a claimant's radiation 
exposure, gender, age at diagnosis, and age at exposure to calculate 
the probability of causation for a given pattern and level of radiation 
exposure.
    (h) Internal dose: The portion of the equivalent dose that is 
received from radioactive materials taken into the body.
    (i) Inverse dose rate effect: A phenomenon in which the protraction 
of an exposure to a potential health hazard leads to greater biological 
effect per unit of dose than the delivery of the same total amount in a 
single dose. An inverse dose rate effect implies that the

[[Page 50975]]

dose and dose rate effectiveness factor (DDREF) is less than one for 
chronic or low doses.
    (j) Linear energy transfer (LET): The average amount of energy 
transferred to surrounding body tissues per unit of distance the 
radiation travels through body tissues (track length). Low LET 
radiation is typified by gamma and x rays, which have high penetrating 
capabilities through various tissues, but transfer a relatively small 
amount of energy to surrounding tissue per unit of track length. High 
LET radiation includes alpha particles and neutrons, which have weaker 
penetrating capability but transfer a larger amount of energy per unit 
of track length.
    (k) NIOSH: The National Institute for Occupational Safety and 
Health, Centers for Disease Control and Prevention, United States 
Department of Health and Human Services.
    (l) Non-radiogenic cancer: A type of cancer that HHS has found not 
to be caused by radiation, for the purposes of this regulation.
    (m) Primary cancer: A cancer defined by the original body site at 
which the cancer was incurred, prior to any spread (metastasis) to 
other sites in the body.
    (n) Probability of causation: The probability or likelihood that a 
cancer was caused by radiation exposure incurred by a covered employee 
in the performance of duty. In statistical terms, it is the cancer risk 
attributable to radiation exposure divided by the sum of the baseline 
cancer risk (the risk to the general population) plus the cancer risk 
attributable to the radiation exposure.
    (o) Radioepidemiological tables: Tables that allow computation of 
the probability of causation for various cancers associated with a 
defined exposure to radiation, after accounting for factors such as age 
at exposure, age at diagnosis, and time since exposure.
    (p) Relative biological effectiveness (RBE): A factor applied to a 
risk model to account for differences between the amount of cancer 
effect produced by different forms of radiation. For purposes of 
EEOICPA, the RBE is considered equivalent to the radiation weighting 
factor.
    (q) Risk model: A mathematical model used under EEOICPA to estimate 
a specific probability of causation using information on radiation 
dose, cancer type, and personal data (e.g., gender, smoking history).
    (r) Secondary site: A body site to which a primary cancer has 
spread (metastasized).
    (s) Specified cancer: A term defined in section 3621(17) of EEOICPA 
and 20 CFR Sec. 30.5(dd) that specifies types of cancer that, pursuant 
to 20 CFR part 30, may qualify a member of the Special Exposure Cohort 
for compensation. It includes leukemia (other than chronic lymphocytic 
leukemia), multiple myeloma, non-Hodgkin's lymphoma, and cancers of the 
lung (other than carcinoma in situ diagnosed at autopsy), thyroid, male 
breast, female breast, esophagus, stomach, pharynx, small intestine, 
pancreas, bile ducts, gall bladder, salivary gland, urinary bladder, 
brain, colon, ovary, liver (not associated with cirrhosis or 
hepatitis), and bone. Pursuant to section 2403 of Pub. L. 107-20, this 
definition will include renal cancer effective October 1, 2001.
    (t) Uncertainty: A term used in this rule to describe the lack of 
precision of a given estimate, the extent of which depends upon the 
amount and quality of the evidence or data available.
    (u) Uncertainty distribution: A statistical term meaning a range of 
discrete or continuous values arrayed around a central estimate, where 
each value is assigned a probability of being correct.
    (v) Upper 99 percent confidence interval: A term used in EEOICPA to 
mean credibility limit, the probability of causation estimate 
determined at the 99th percentile of the range of uncertainty around 
the central estimate of probability of causation.

Subpart C--Data Required To Estimate Probability of Causation


Sec. 81.5  Use of personal and medical information

    Determining probability of causation may require the use of the 
following personal and medical information provided to DOL by claimants 
under DOL regulations 20 CFR part 30:
    (a) Year of birth.
    (b) Cancer diagnosis (by ICD-9 code) for primary and secondary 
cancers.
    (c) Date of cancer diagnosis.
    (d) Gender.
    (e) Race/ethnicity (if the claim is for skin cancer or a secondary 
cancer for which skin cancer is a likely primary cancer).
    (f) Smoking history (if the claim is for lung cancer or a secondary 
cancer for which lung cancer is a likely primary cancer).


Sec. 81.6  Use of radiation dose information.

    Determining probability of causation will require the use of 
radiation dose information provided to DOL by the National Institute 
for Occupational Safety and Health (NIOSH) under HHS regulations 42 CFR 
part 82. This information will include annual dose estimates for each 
year in which a dose was incurred, together with uncertainty 
distributions associated with each dose estimate. Dose estimates will 
be distinguished by type of radiation (low linear energy transfer 
(LET), protons, neutrons, alpha, low-energy x-ray) and by dose rate 
(acute or chronic) for external and internal radiation dose.

Subpart D--Requirements for Risk Models Used To Estimate 
Probability of Causation


Sec. 81.10  Use of cancer risk assessment models in NIOSH IREP.

    (a) The risk models used to estimate probability of causation for 
covered employees under EEOICPA will be based on risk models updated 
from the 1985 NIH radioepidemiological tables. These 1985 tables were 
developed from analyses of cancer mortality risk among the Japanese 
atomic bomb survivor cohort. The National Cancer Institute (NCI) and 
Centers for Disease Control and Prevention (CDC) are updating the 
tables, replacing them with a sophisticated analytic software program. 
This program, the Interactive RadioEpidemiological Program (IREP), 
models the dose-response relationship between ionizing radiation and 33 
cancers using morbidity data from the same Japanese atomic bomb 
survivor cohort. In the case of thyroid cancer, radiation risk models 
are based on a pooled analysis of several international cohorts.\1\
---------------------------------------------------------------------------

    \1\ Ron E, Lubin JH, Shore RE, et al. ``Thyroid cancer after 
exposure to external radiation: a pooled analysis of seven 
studies.'' Radiat. Res. 141:259-277, 1995.
---------------------------------------------------------------------------

    (b) NIOSH will change the risk models in IREP, as needed, to 
reflect the radiation exposure and disease experiences of employees 
covered under EEOICPA, which differ from the experiences of the 
Japanese atomic bomb survivor cohort. Changes will be incorporated in a 
version of IREP named NIOSH-IREP, specifically designed for 
adjudication of claims under EEOICPA. Possible changes in IREP risk 
models include the following:
    (1) Addition of risk models to IREP as needed for claims under 
EEOICPA (e.g., bone cancer, malignant melanoma and other skin cancers).
    (2) Modification of IREP risk models to incorporate radiation 
exposures unique to employees covered by EEOICPA (e.g., radon and low 
energy x rays from employer-required medical screening programs, 
adjustment of relative biological effectiveness distributions based on 
neutron energy).
    (3) Modification of IREP risk models to incorporate new 
understanding of radiation-related cancer effects relevant

[[Page 50976]]

to employees covered by EEOICPA (e.g., incorporation of inverse dose-
rate relationship between high LET radiation exposures and cancer; 
removal of the low-dose effect reduction factor for acute exposures).
    (4) Modification of IREP risk models to incorporate temporal, race 
and ethnicity-related differences in the frequency of certain cancers 
occurring generally among the U.S. population.
    (5) Modifications of IREP to facilitate improved evaluation of the 
uncertainty distribution for the probability of causation for claims 
based on two or more primary cancers.


Sec. 81.11  Use of uncertainty analysis in NIOSH-IREP.

    (a) EEOICPA requires use of the uncertainty associated with the 
probability of causation calculation, specifically requiring the use of 
the upper 99% confidence interval estimate of the probability of 
causation estimate. As described in the NCI document \2\, uncertainty 
from several sources is incorporated into the probability of causation 
calculation performed by IREP. These sources include uncertainties in 
estimating: Radiation dose incurred by the covered employee; the 
radiation dose-cancer relationship (statistical uncertainty in the 
specific cancer risk model); the extrapolation of risk (risk transfer) 
from the Japanese to the U.S. population; differences in the amount of 
cancer effect caused by different radiation types (relative biological 
effectiveness or RBE); the relationship between the rate at which a 
radiation dose is incurred and the level of cancer risk produced (dose 
and dose rate effectiveness factor or DDREF); and, the role of non-
radiation risk factors (such as smoking history).
---------------------------------------------------------------------------

    \2\ Draft Report of the NCI-CDC Working Group to Revise the 1985 
NIH Radioepidemiological Tables, May 31, 2000, p. 17-18, p. 22-23.
---------------------------------------------------------------------------

    (b) NIOSH-IREP will operate according to the same general protocol 
as IREP for the analysis of uncertainty. It will address the same 
possible sources of uncertainty affecting probability of causation 
estimates, and in most cases will apply the same assumptions 
incorporated in IREP risk models. Different procedures and assumptions 
will be incorporated into NIOSH-IREP as needed, according to the 
criteria outlined under Sec. 81.10.

Subpart E--Guidelines To Estimate Probability of Causation


Sec. 81.20  Required use of NIOSH-IREP.

    (a) NIOSH-IREP is an online interactive software program for 
estimating probability of causation for covered employees seeking 
compensation for cancer under EEOICPA, other than as members of the 
Special Exposure Cohort seeking compensation for a specified cancer.
    (b) DOL is required to use NIOSH-IREP to estimate probability of 
causation for all cancers, as identified under Secs. 81.21 and 81.23.


Sec. 81.21  Cancers requiring the use of NIOSH-IREP.

    (a) DOL will calculate probability of causation for all cancers, 
except Chronic Lymphocytic Leukemia as provided under Sec. 81.30, using 
NIOSH-IREP.
    (b) Carcinoma in situ (ICD-9 codes 230-234), neoplasms of uncertain 
behavior (ICD-9 codes 235-238), and neoplasms of unspecified nature 
(ICD-9 code 239) are assumed to be malignant, for purposes of 
estimating probability of causation.
    (c) All secondary and unspecified cancers of the lymph node (ICD-9 
code 196) shall be considered secondary cancers (cancers resulting from 
metastasis of cancer from a primary site). For claims identifying 
cancers of the lymph node, Table 1 in Sec. 81.23 provides guidance for 
assigning a primary site and calculating probability of causation using 
NIOSH-IREP.


Sec. 81.22  General guidelines for use of NIOSH-IREP.

    DOL will use procedures specified in the NIOSH-IREP Operating Guide 
to calculate probability of causation estimates under EEOICPA. The 
guide provides current, step-by-step instructions for the operation of 
IREP. The procedures include entering personal, diagnostic, and 
exposure data; setting/confirming appropriate values for variables used 
in calculations; conducting the calculation; and, obtaining, 
evaluating, and reporting results.


Sec. 81.23  Guidelines for cancers for which primary site is unknown.

    (a) In claims for which the primary cancer site cannot be 
determined, but a site of metastasis is known, DOL will calculate 
probability of causation estimates for various likely primary sites. 
Table 1 of this section indicates the primary cancer site(s) DOL will 
use in NIOSH-IREP when the primary cancer site is unknown:

Table 1--Primary Cancer Sites

Primary cancers (ICD-9 codes \3\) for which probability of causation is 
to be calculated, if only a secondary cancer site is known. ``M'' 
indicates cancer site should be used for males only, and ``F'' 
indicates cancer site should be used for females only. A glossary of 
cancer descriptions for each ICD-9 code is provided in appendix A to 
this part.
---------------------------------------------------------------------------

    \3\ The International Classification of Diseases Clinical 
Modification (9th Revision) Volume I&II. [1991] Department of Health 
and Human Services Publication No. (PHS) 91-1260, U.S. Government 
Printing Office, Washington, D.C.

------------------------------------------------------------------------
                                           ICD-9 code of likely primary
     Secondary cancer  (ICD-9 code)                  cancers
------------------------------------------------------------------------
Lymph nodes of head, face and neck       141, 142 (M), 146 (M), 149 (F),
 (196.0).                                 161 (M), 162, 172, 173, 174
                                          (F), 193 (F)
Intrathoracic lymph nodes (196.1)......  150 (M), 162, 174 (F)
Intra-abdominal lymph nodes (196.2)....  150 (M), 151 (M), 153, 157 (F),
                                          162, 174 (F), 180 (F), 185
                                          (M), 189, 202 (F)
Lymph nodes of axilla and upper limb,    162, 172, 174 (F)
 (196.3).
Inguinal and lower, limb lymph nodes,    154 (M), 162, 172, 173 (F), 187
 (196.5).                                 (M)
Intrapelvic lymph nodes (196.6)........  153 (M), 154 (F), 162 (M), 180
                                          (F), 182 (F), 185 (M), 188
Lymph nodes of multiple sites, (196.8).  150 (M), 151 (M), 153 (M), 162,
                                          174 (F)
Lymph nodes, site unspecified (196.9)..  150 (M), 151, 153, 162, 172,
                                          174 (F), 185 (M)
Lung (197.0)...........................  153, 162, 172 (M), 174 (F), 185
                                          (M), 188 (M), 189
Mediastinum (197.1)....................  150 (M), 162, 174 (F)
Pleura (197.2).........................  150 (M), 153 (M), 162, 174 (F),
                                          183 (F), 185 (M), 189 (M)
Other respiratory Organs (197.3).......  150, 153 (M), 161, 162, 173
                                          (M), 174 (F), 185 (M), 193
Small intestine, including duodenum      152, 153, 157, 162, 171, 172
 (197.4).                                 (M), 174 (F), 183 (F), (f),
                                          183 (f), 189 (M)
Large intestine and rectum (197.5).....  153, 154, 162, 174 (F), 183
                                          (F), 185 (M)
Retroperitoneum and peritoneum (197.6).  151, 153, 154 (M), 157, 162
                                          (M), 171, 174 (F), 182 (F),
                                          183 (F)

[[Page 50977]]

 
Liver, specified as secondary (197.7)..  151 (M), 153, 154 (M), 157,
                                          162, 174 (F)
Other digestive organs (197.8).........  150 (M), 151, 153, 157, 162,
                                          174 (F), 185 (M)
Kidney (198.0).........................  153, 162, 174 (F), 180 (F), 185
                                          (M), 188, 189, 202 (F)
Other urinary organs (198.1)...........  153, 174 (F), 180 (F), 183 (F),
                                          185 (M), 188, 189 (F)
Skin (198.2)...........................  153, 162, 171 (M), 172, 173
                                          (M), 174 (F), 189 (M)
Brain and spinal cord (198.3)..........  162, 172 (M), 174 (F)
Other parts of nervous system, (198.4).  162, 172 (M), 174 (F), 185 (M),
                                          202
Bone and bone marrow (198.5)...........  162, 174 (F), 185 (M)
Ovary (198.6)..........................  153 (F), 174 (F), 183 (F)
Suprarenal gland (198.7)...............  153 (F), 162, 174 (F)
Other specified sites (198.8)..........  153, 162, 172 (M), 174 (F), 183
                                          (F), 185 (M), 188 (M)
------------------------------------------------------------------------

    (b) DOL will select the site producing the highest estimate for 
probability of causation to adjudicate the claim.


Sec. 81.24  Guidelines for leukemia.

    (a) For claims involving leukemia, DOL will calculate one or more 
probability of causation estimates from among three of the four 
alternate leukemia risk models included in NIOSH-IREP, as specified in 
the NIOSH-IREP Operating Guide. These include: ``Leukemia, all types 
except CLL'' (IDC-9 codes: 204-208, except 204.1), ``acute lymphocytic 
leukemia'' (ICD-9 code: 204.0), and ``acute myelogenous leukemia'' 
(ICD-9 code: 205.0).
    (b) For leukemia claims in which DOL calculates multiple 
probability of causation estimates, as specified in the NIOSH-IREP 
Operating Guide, the probability of causation estimate DOL assigns to 
the claim will be based on the leukemia risk model producing the 
highest estimate for probability of causation.


Sec. 81.25  Guidelines for claims including two or more primary 
cancers.

    (a) For claims including two or more primary cancers, DOL will use 
NIOSH-IREP to calculate the estimated probability of causation for each 
cancer individually. Then DOL will perform the following calculation 
using the probability of causation estimates produced by NIOSH-IREP:


Equation 1
Calculate: 1- [{1 - PC1}  x  {1 - PC2}  x  * * * 
x  {1 - PCn} = PCtotal,

    Where PC1 is the probability of causation for one of the 
primary cancers identified in the claim, PC2 is the 
probability of causation for a second primary cancer identified in the 
claim, and PCn is the probability of causation for the nth 
primary cancer identified in the claim. PCtotal is the 
probability that at least one of the primary cancers (cancers 1 through 
``n'') was caused by the radiation dose estimated for the claim when 
Equation 1 is evaluated based on the joint distribution of 
PC1, * * *, PCn.\4\
---------------------------------------------------------------------------

    \4\ Evaluating Equation 1 based on the individual upper 99th 
percentiles of PC1, * * *, PCn approximates 
the upper 99th percentile of PCtotal whenever 
PC1, * * *, PCn are highly related, e.g., when 
a common dose-reconstruction is the only non-negligible source of 
uncertainty in the individual PCi's. However, this 
approximation can overestimate it if other sources of uncertainty 
contribute independently to the PC1, * * *, 
PCn, whereas treating the joint distribution as fully 
independent could substantially underestimate the upper 99th 
percentile of PCtotal whenever the individual 
PCi's are positively correlated.
---------------------------------------------------------------------------


Sec. 81.30  Non-radiogenic cancers.

    The following cancers are considered non-radiogenic for the 
purposes of EEOICPA and this part. DOL will assign a probability of 
causation of zero to the following cancers: Chronic lymphocytic 
leukemia (ICD-9 code: 204.1).

Appendix A to Part 81--Glossary of ICD-9 Codes and Their Cancer 
Descriptions

------------------------------------------------------------------------
           ICD-9 code                       Cancer description
------------------------------------------------------------------------
140.............................  Malignant neoplasm of lip.
141.............................  Malignant neoplasm of tongue.
142.............................  Malignant neoplasm of major salivary
                                   glands.
143.............................  Malignant neoplasm of gum.
144.............................  Malignant neoplasm of floor of mouth.
145.............................  Malignant neoplasm of other and
                                   unspecified parts of mouth.
146.............................  Malignant neoplasm of oropharynx.
147.............................  Malignant neoplasm of nasopharynx.
148.............................  Malignant neoplasm of hypopharynx.
149.............................  Malignant neoplasm of other and ill-
                                   defined sites within the lip, oral
                                   cavity, and pharynx.
150.............................  Malignant neoplasm of esophagus.
151.............................  Malignant neoplasm of stomach.
152.............................  Malignant neoplasm of small intestine,
                                   including duodenum.
153.............................  Malignant neoplasm of colon.
154.............................  Malignant neoplasm of rectum,
                                   rectosigmoid junction, and anus.
155.............................  Malignant neoplasm of liver and
                                   intrahepatic bile ducts.
156.............................  Malignant neoplasm of gall bladder and
                                   extrahepatic bile ducts.
157.............................  Malignant neoplasm of pancreas.
158.............................  Malignant neoplasm of retroperitoneum
                                   and peritoneum.
159.............................  Malignant neoplasm of other and ill-
                                   defined sites within the digestive
                                   organs and peritoneum.
160.............................  Malignant neoplasm of nasal cavities,
                                   middle ear, and accessory sinuses.
161.............................  Malignant neoplasm of larynx.
162.............................  Malignant neoplasm of trachea,
                                   bronchus and lung.
163.............................  Malignant neoplasm of pleura.
164.............................  Malignant neoplasm of thymus, heart,
                                   and mediastinum.
165.............................  Malignant neoplasm of other and ill-
                                   defined sites within the respiratory
                                   system and intrathoracic organs.
170.............................  Malignant neoplasm of bone and
                                   articular cartilage.
171.............................  Malignant neoplasm of connective and
                                   other soft tissue.
172.............................  Malignant melanoma of skin.
173.............................  Other malignant neoplasms of skin.
174.............................  Malignant neoplasm of female breast.
175.............................  Malignant neoplasm of male breast.
179.............................  Malignant neoplasm of uterus, part
                                   unspecified.
180.............................  Malignant neoplasm of cervix uteri.
181.............................  Malignant neoplasm of placenta.
182.............................  Malignant neoplasm of body of uterus.
183.............................  Malignant neoplasm of ovary and other
                                   uterine adnexa.
184.............................  Malignant neoplasm of other and
                                   unspecified female genital organs.
185.............................  Malignant neoplasm of prostate.
186.............................  Malignant neoplasm of testis.
187.............................  Malignant neoplasm of penis and other
                                   male genital organs.
188.............................  Malignant neoplasm of urinary bladder.

[[Page 50978]]

 
189.............................  Malignant neoplasm of kidney and other
                                   and unspecified urinary organs.
190.............................  Malignant neoplasm of eye.
191.............................  Malignant neoplasm of brain.
192.............................  Malignant neoplasm of other and
                                   unspecified parts of nervous system.
193.............................  Malignant neoplasm of thyroid gland.
194.............................  Malignant neoplasm of other endocrine
                                   glands and related structures.
195.............................  Malignant neoplasm of other and ill-
                                   defined sites.
196.............................  Secondary and unspecified malignant
                                   neoplasm of the lymph nodes.
197.............................  Secondary malignant neoplasm of the
                                   respiratory and digestive organs.
198.............................  Secondary malignant neoplasm of other
                                   tissue and organs.
199.............................  Malignant neoplasm without
                                   specification of site.
200.............................  Lymphosarcoma and reticulosarcoma.
201.............................  Hodgkin's disease.
202.............................  Other malignant neoplasms of lymphoid
                                   and histiocytic tissue.
203.............................  Multiple myeloma and other
                                   immunoproliferative neoplasms.
204.............................  Lymphoid leukemia.
205.............................  Myeloid leukemia.
206.............................  Monocytic leukemia.
207.............................  Other specified leukemia.
208.............................  Leukemia of unspecified cell type.
------------------------------------------------------------------------
\1\ The International Classification of Diseases Clinical Modification
  (9th Revision) Volume I&II. [1991] Department of Health and Human
  Services Publication No. (PHS) 91-1260, U.S. Government Printing
  Office, Washington, DC.


    Dated: September 21, 2001.
Tommy G. Thompson,
Secretary, Department of Health and Human Services.

[FR Doc. 01-24878 Filed 10-4-01; 8:45 am]
BILLING CODE 4160-17-P